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No REMS Needed for Gene Therapy: FDA

[ Price : $8.95]

FDA denies a petition seeking Risk Evaluation and Mitigation Strategiesfor Behrings simultaneously approved Hemophilia B gene ther...

Device Color Additive Risk Calculator Qualified

[ Price : $8.95]

CDRH qualifies the CHemical RISk calculator Color Additives under its Medical Device Development Tools program.

2nd Alzheimers Therapy Death Raises Questions: Journal

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The journal Science says safety questions are being raised about Eisai and Biogens lecanemab (BAN2401), an investigational anti-am...

FDA Rejects Spectrum's Lung Cancer Drug

[ Price : $8.95]

FDA sends Spectrum Pharmaceuticals a complete response letter rejecting the companys poziotinib and its use in treating certain pa...

Panel to Discuss Regenerons Aflibercept Pediatric Use

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Federal Register notice: FDA announces a 1/9 Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a Regeneron P...

Luer-Activated Valve Connector FDA Alert

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FDA alerts healthcare professionals about potential compatibility issues with prefilled glass syringes and certain Luer-activated ...

CDER Proposes to Withdraw Bufferin NDA

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Federal Register notice: CDER proposes to withdraw the approval of an NDA 006499 for Bufferin (aspirin) tablets because it has not...

FDA Clears RapidAI Intracranial Hemorrhage Triage Device

[ Price : $8.95]

FDA clears a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage (ICH) triage and notification device.

Janssen Says Spravato Tops Seroquel in Trial

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Janssen says results of a head-to-head trial showed its Spravato had superior efficacy to Seroquel in patients with treatment-resi...

EUA for Lucira Covid-19 and Flu Test

[ Price : $8.95]

FDA approves an emergency use authorization for the Lucira Covid-19 and Flu Test.